Statistical modeling for Bayesian extrapolation of adult clinical trial information in pediatric drug evaluation

Children represent a large underserved population of “therapeutic orphans,” as an estimated 80% of children are treated off‐label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population. The Bayesian statistical paradigm is natural in this setting, as it permits the combining (or “borrowing”) of information across disparate sources, such as the adult and pediatric data. In this paper, authored by the pediatric subteam of the Drug Information Association Bayesian Scientific Working Group and Adaptive Design Working Group, we develop, illustrate, and provide suggestions on Bayesian statistical methods that could be used to design improved pediatric development programs that use all available information in the most efficient manner. A variety of relevant Bayesian approaches are described, several of which are illustrated through 2 case studies: extrapolating adult efficacy data to expand the labeling for Remicade to include pediatric ulcerative colitis and extrapolating adult exposure‐response information for antiepileptic drugs to pediatrics.     

The importance of ergonomics to sustainability throughout a building's life cycle

Protecting and conserving environmental resources is a global concern. Over the past decade, a number of certification processes have emerged to help designers and operators of buildings assess the potential impact of a building on the environment. Certifications such as the Leadership in Energy and Environmental Design (LEED) consider the environmental impact through the lifecycle of a building, but may not be considering the people that construct and utilize it. It is important to remember the human factor. Considering the human factor throughout the lifecycle is crucial to ensure individuals are protected during construction and in operation in the built environment. The paper highlights how ergonomics can be integrated into the life cycle of a building to promote sustainability goals for both the human factor and the environment. A case study approach will be used to illustrate how ergonomics was integrated into a LEED renovation and expanded into its daily operations on a large university campus..     

Contributions of Maternal Adult Attachment to Socialization of Coping

This research examined whether maternal adult attachment predicted the coping suggestions mothers made to their children. A sample of 157 youth (M age = 12.42, SD = 1.20) and their maternal caregivers completed semi-structured interviews and questionnaires in a two-wave longitudinal study. Results revealed that maternal insecure attachment predicted fewer engagement coping suggestions (orienting toward stress) and heightened disengagement coping suggestions (avoiding or denying stress) both concurrently and over time. These associations were found after adjusting for other relevant characteristics of the child, mother, and family context. This study contributes to our understanding of the implications of adult attachment for parenting behavior, suggesting that insecure attachment undermines a parent's ability to provide adaptive coping guidance to their children.     

Financial Strain,Negative Interaction,Coping Styles,and Mental Health Among Low-Income Latinos

This study examines the relationship between financial strain and depressive symptoms in later life, and potential psychosocial mediators of this relationship. Drawing on a sample of 214 low-income Latino older adults, we used structural equation modeling to test the direct effect of chronic financial strain on depressive symptomatology, and the indirect effects via social support, negative interaction, and coping styles. Findings indicated that financial strain increased the level of depressive symptoms among this sample. Avoidance and approach-related coping styles emerged as independent determinants of depressive symptoms albeit in opposite directions; higher levels of avoidance coping was associated with higher levels of depressive symptoms. Contrary to previous findings on the general population, findings from the current study indicate that social support and negative interaction were not directly associated with depressive symptoms. Financial strain mediated the effect of sociocultural (nativity status, years of U.S. residence) and social status factors (age, education) on depressive symptoms. This study highlights the differential impact of financial strain and coping styles on psychological well-being, and the potential psychosocial targets of interventions for older adults with chronic health care conditions.     

Cybersex: The Impact of a Contemporary Problem on the Practices of Marriage and Family Therapists

The number of people accessing the Internet for sexual purposes (cybersex) has increased dramatically over the last 10 years. However, little research has been conducted to determine how frequently clients present for treatment with cybersex‐related issues. One hundred sixty‐four clinical members of the American Association for Marriage and Family Therapy participated in the current study, which was conducted to identify the impacts of cybersex on MFTs’ practices. Most respondents report seeing clients with cybersex‐related issues, with client numbers increasing over the past 2 years. Although most respondents felt prepared to diagnose and treat adults with cybersex problems, half felt unprepared to diagnose and treat children. Lastly, most respondents reported that their required college courses were not helpful in preparing them to diagnose and treat cybersex‐related problems. The implications of study findings are discussed.     

Reconstructing child welfare through participatory and child‐centred professional practice: a conceptual approach1

The ‘child’ in child welfare/protection is seen as a dependent waif and an object of interest, on whose behalf adults speak and act. An alternative perspective has argued for child‐centredness, and includes concepts of child liberation, rights and citizenship. Policymakers and practitioners who may accept the underlying principles may be concerned about the appropriateness and applicability of such principles in relation to practice with children and their parents in child welfare/protection cases. This paper discusses a conceptual framework for research that aims to explore participatory and child‐centred professional practice by critically evaluating and developing, for professional practice, the practical meanings of ‘participatory’ and ‘children as citizens’. We do not present research outcomes based on empirical data; instead, we present our conceptual framework as the first stage of research in progress into participatory and child‐centred professional practice.     

Ecocultural Attributes: Evaluating Ecological Degradation in Terms of Ecological Goods and Services Versus Subsistence and Tribal Values

It is becoming increasingly clear that scientists, managers, lawyers, public policymakers, and the public must decide how to value what is provided by, and is a consequence of, natural resources. While “Western” scientists have clear definitions for the goods and services that ecosystems provide, we contend that these categories do not encompass the full totality of the values provided by natural resources. Partly the confusion results from a limited view of natural resources derived from the need to monetize the value of ecosystems and their component parts. Partly it derives from the “Western” way of separating natural resources from cultural resources or values, and partly it derives from the false dichotomy of assuming that ecosystems are natural, and anything constructed by man is not natural. In this article, we explore the previous assumptions, and suggest that because cultural resources often derive from, and indeed require, intact and unspoiled natural ecosystems or settings, that these values are rightly part of natural resources. The distinction is not trivial because of the current emphasis on cleaning up chemically and radiologically contaminated sites, on restoration of damaged ecosystems, on natural resource damage assessments, and on long‐term stewardship goals. All of these processes depend upon defining natural resources appropriately. Several laws, regulations, and protocols depend upon natural resource trustees to protect natural resources on trust lands, which could lead to the circular definition that natural resources are those resources that the trustees feel they are responsible for. Where subsistence or tribal peoples are involved, the definition of natural resources should be broadened to include those ecocultural attributes that are dependent upon, and have incorporated, natural resources. For example, a traditional hunting and fishing ground is less valued by subsistence peoples if it is despoiled by contamination or physical ecosystem degradation; an Indian sacred ground is tarnished if the surrounding natural environment is degraded; a traditional homeland is less valued if the land itself is contaminated. Our argument is that intact natural resources are essential elements of many cultural resources, and this aspect requires and demands adequate consideration (and may therefore require compensation).